Computer-Based Cognitive Behavioral Therapy for Chronic Pain in Opioid Treatment

(IMPACT Trial)

No longer recruiting at 2 trial locations

Overseen By TBN

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Yale University

Must be taking: Methadone, Buprenorphine

Disqualifiers: Bipolar, Psychotic disorder, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 16

Duration: 12 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new online program designed to assist individuals with chronic pain who are already receiving opioid treatment, such as methadone or buprenorphine. The program, CBT4CBT COPES, combines cognitive behavioral therapy (CBT), which teaches coping skills, with daily check-ins to improve pain management. The trial will compare this new approach to standard care to determine which is more effective in improving pain and treatment adherence. Individuals who have experienced moderate to severe chronic pain for at least six months and are currently in opioid treatment may be suitable candidates. As an unphased trial, this study provides a unique opportunity to explore innovative pain management strategies beyond standard care.

Do I have to stop taking my current medications to join the trial?

The trial does not specify if you need to stop taking your current medications. However, participants must be enrolled in methadone or buprenorphine treatment, so you should continue those medications.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, it does require participants to be on methadone or buprenorphine treatment.

What prior data suggests that this computer-based cognitive behavioral therapy is safe for individuals with chronic pain?

Research has shown that CBT4CBT-COPES has been tested in several studies. This online program helps individuals manage pain and substance use. More than eight clinical trials have found CBT4CBT more effective at reducing drug or alcohol use than standard treatments.

These studies do not report any specific side effects or problems with CBT4CBT-COPES. As an online therapy, it is generally considered safe. The program incorporates methods from CBT (cognitive behavioral therapy) and COPES (Cooperative Pain Education and Self-management), both well-received in past research.

Focusing on teaching and self-management, and with no reported safety issues, it is likely to be well-tolerated. However, potential participants should discuss any concerns with the trial team or their healthcare provider. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the CBT4CBT COPES treatment for chronic pain in opioid treatment because it takes a digital approach to cognitive behavioral therapy (CBT). Unlike traditional methods that rely on face-to-face therapy sessions, this treatment uses an online platform, allowing individuals to access therapy materials anytime. This flexibility can enhance accessibility and consistency in treatment. Additionally, the integration of daily text messages with survey links helps to engage patients regularly, providing continuous support and monitoring. This innovative use of technology aims to improve patient outcomes by making therapy more adaptable to individual needs.

What evidence suggests that CBT4CBT-COPES might be an effective treatment for chronic pain?

Research has shown that the CBT4CBT-COPES program, which participants in this trial may receive, might assist people with chronic pain who use methadone or buprenorphine. Previous studies found that the CBT4CBT program helps individuals reduce drug or alcohol use more effectively than standard treatments. This program teaches skills to address thinking and behavior challenges. The COPES component aids in managing chronic pain and daily activities. Together, these elements aim to enhance pain management and adherence to medication plans. This combination could offer a promising option for those facing both chronic pain and substance use issues. ^{1 2 3 4 5}

Who Is on the Research Team?

Alicia Heapy, PhD

Principal Investigator

Yale University

Are You a Good Fit for This Trial?

Adults over 18 with opioid use disorder (OUD) who are on methadone or buprenorphine treatment and have chronic pain. They must be able to walk a block, speak English at a basic level, and not have severe health issues or untreated mental disorders that could interfere with the study.

Inclusion Criteria

You meet the official guidelines for opioid use disorder (OUD) according to the DSM-5.

I am currently in a methadone or buprenorphine program at Liberation.

I can walk at least one block by myself.

Exclusion Criteria

I am scheduled for surgery to manage my pain.

Pending legal action or planned relocation that makes it unlikely they would be able to complete the study

I do not have any severe health conditions that would prevent me from participating.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Treatment

Participants receive CBT4CBT-COPES or standard care for 12 weeks, with weekly meetings and assessments

12 weeks

12 visits (in-person or virtual)

Follow-up

Participants are monitored for safety and effectiveness after treatment, with follow-up interviews at 1, 3, and 6 months post-treatment

6 months

3 visits (in-person or virtual)

What Are the Treatments Tested in This Trial?

Interventions

• CBT4CBT COPES

Trial Overview The trial is testing an integrated web-based program combining cognitive-behavioral therapy (CBT4CBT) and Cooperative Pain Education Self-Management (COPES). It aims to improve adherence to medication-assisted treatment for OUD and manage chronic pain better than standard care alone.

How Is the Trial Designed?

Group I: CBT4CBT-Copes Experimental Treatment 1 Intervention

Individuals will receive standard agonist treatment plus access to the CBT4CBT-COPES website plus daily texts with a link to a survey.

Group II: Standard care treatment as usual (TAU) Active Control 1 Intervention

Individuals will receive buprenorphine or methadone in addition to regular individual or group sessions as offered by the clinic

CBT4CBT COPES is already approved in United States for the following indications:

Approved in United States as CBT4CBT COPES for:

• Chronic pain management in individuals treated with buprenorphine or methadone

Who Is Running the Clinical Trial?

Yale University

Lead Sponsor

Trials

1,963

Recruited

3,046,000+

National Center for Complementary and Integrative Health (NCCIH)

Collaborator

Trials

886

Recruited

677,000+

National Institutes of Health (NIH)

Collaborator

Trials

2,896

Recruited

8,053,000+

Published Research Related to This Trial

A randomized non-inferiority trial is being conducted with 230 patients suffering from chronic low back pain to compare the effectiveness of traditional in-person cognitive behavioral therapy (CBT) with an innovative interactive voice response (IVR)-based CBT, aiming to enhance access to treatment.

The primary goal is to assess pain intensity immediately after treatment, while secondary outcomes will evaluate pain-related interference, emotional functioning, and quality of life over time, potentially demonstrating that IVR-based CBT can effectively provide care to more patients without compromising treatment efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cooperative pain education and self-management (COPES): study design and protocol of a randomized non-inferiority trial of an interactive voice response-based self-management intervention for chronic low back pain. Heapy, AA., Higgins, DM., LaChappelle, KM., et al.[2022]

A survey of 152 physical therapists revealed that while only a minority currently use cognitive-behavioral therapy (CBT) techniques like activity pacing (81%) and pleasurable activity scheduling (30%) for treating older patients with chronic pain, there is a significant interest in incorporating these methods into practice.

Barriers to using CBT include a lack of knowledge and skills, concerns about reimbursement, and time constraints, indicating that addressing these issues could enhance the integration of CBT into physical therapy for chronic pain management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Physical therapists' use of cognitive-behavioral therapy for older adults with chronic pain: a nationwide survey. Beissner, K., Henderson, CR., Papaleontiou, M., et al.[2021]

In a study involving 290 veterans with chronic back pain, 54% declined to participate in cognitive behavioral therapy for chronic pain (CBT-CP) due to lack of interest, indicating low overall enrollment rates.

Patients not receiving opioid prescriptions were more likely to enroll in the trial, suggesting that those on opioids, who may benefit from alternative pain management strategies, are underrepresented in CBT-CP programs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Predictors of Participation in a Nonpharmacological Intervention for Chronic Back Pain. Higgins, DM., LaChappelle, KM., Serowik, KL., et al.[2019]

Cognitive-behavioral therapy (CBT) is an effective first-line treatment for chronic pain, supported by numerous randomized controlled trials showing improvements in pain and related issues across various chronic pain syndromes.

Recent innovations in CBT delivery, such as web-based and telephone formats, have expanded its accessibility and effectiveness for diverse populations, including children and older adults, indicating a promising direction for future treatment approaches.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cognitive-behavioral therapy for individuals with chronic pain: efficacy, innovations, and directions for research. Ehde, DM., Dillworth, TM., Turner, JA.[2022]

The COPES trial demonstrated that interactive voice response-based cognitive behavioral therapy (IVR-CBT) is as effective as in-person CBT for managing chronic back pain, with similar reductions in pain intensity after 3 months.

IVR-CBT also showed lower dropout rates, suggesting it may be a more accessible and convenient option for patients, enhancing their ability to engage in treatment compared to traditional in-person therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Interactive Voice Response-Based Self-management for Chronic Back Pain: The COPES Noninferiority Randomized Trial. Heapy, AA., Higgins, DM., Goulet, JL., et al.[2019]

A study involving 278 patients with chronic back pain found that an AI-driven cognitive behavioral therapy for chronic pain (AI-CBT-CP) was noninferior to standard telephone CBT-CP, showing similar effectiveness in reducing disability and pain over 6 months.

AI-CBT-CP not only achieved better clinical outcomes for patients but also required less than half the therapist time compared to traditional CBT-CP, suggesting it could improve access to treatment for more patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patient-Centered Pain Care Using Artificial Intelligence and Mobile Health Tools: A Randomized Comparative Effectiveness Trial. Piette, JD., Newman, S., Krein, SL., et al.[2023]

Web-based cognitive behavioral therapy (CBT) effectively reduced pain interference and intensity in patients with chronic musculoskeletal pain, regardless of whether they received additional phone-based support from nurses.

The study found no significant differences in pain-related outcomes between the group receiving nurse support and the control group, except for a slight improvement in sleep disturbance favoring the nurse support group, suggesting that web-based CBT alone may be a cost-effective treatment option.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Nurse-Supported Web-Based Cognitive Behavioral Therapy for Chronic Musculoskeletal Pain: A Randomized Controlled Trial. Diab, R., Bomar, R., Slaven, J., et al.[2023]

A group-based cognitive behavioral therapy (CBT) intervention for chronic pain, delivered in primary care settings, resulted in significant and sustained reductions in self-reported pain impact and pain-related disability over 12 months among 850 participants.

While the CBT intervention improved patient satisfaction with care and reduced benzodiazepine use, it did not significantly decrease opioid use, indicating that while CBT can help manage chronic pain, it may not affect opioid consumption.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Primary Care-Based Cognitive Behavioral Therapy Intervention for Long-Term Opioid Users With Chronic Pain : A Randomized Pragmatic Trial. DeBar, L., Mayhew, M., Benes, L., et al.[2022]

Citations

1. centerwatch.com centerwatch.com/clinical-trials/listings/NCT05204576/computer-based-treatment-for-cognitive-behavioral-therapy-and-cooperative-pain-education-and-self-management

Computer Based Treatment for Cognitive Behavioral Therapy ... A randomized clinical trial evaluating CBT4CBT-COPES will be conducted in a diverse sample 160 of individuals enrolled in agonist treatment (methadone or ...

2. researchprotocols.org researchprotocols.org/2024/1/e54342

Efficacy of Integrating the Management of Pain and ... Core program features of the Computer-Based Treatment for Cognitive Behavioral Therapy (CBT4CBT) and Cooperative Pain Education and Self- ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10993119/

Efficacy of Integrating the Management of Pain and ... CBT4CBT is a web-based program designed to improve behavioral and cognitive coping skills that have been evaluated in a range of substance use disorders [44-47] ...

4. cbt4cbt.com cbt4cbt.com/

Computer Based Training for Cognitive Behavioral Therapy ... Over 8 clinical trials show: CBT4CBT is more effective in reducing drug or alcohol use than standard substance use treatment. CBT ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7734659/

Co-Operative Pain Education and Self-management (COPES ... This pragmatic superiority trial will determine whether a remotely delivered CBT-CP intervention that addresses these barriers outperforms in-person and other ...